3 CAPA Lead Batch Reviewer Jobs in Baltimore, MD

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CAPA Lead Batch Reviewer

CENTSTONE SERVICES LLC

Baltimore, MD | Contractor

$88k-120k (estimate)

2 Weeks Ago

CAPA Lead Batch Reviewer

Katalyst Healthcares & Life Sciences

Baltimore, MD | Full Time

$88k-120k (estimate)

2 Weeks Ago

Lead Batch Reviewer

GBA Team

Baltimore, MD | Full Time

$100k-127k (estimate)

2 Weeks Ago

CAPA Lead Batch Reviewer

$88k-120k (estimate)

Full Time 2 Weeks Ago

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Katalyst Healthcares & Life Sciences is Hiring a CAPA Lead Batch Reviewer Near Baltimore, MD

Responsibilities:

Lead a team of Batch Record Reviewers performing the following activities: Execute the initiation and/or evaluate deviation(s), interview personnel, analyze root cause, assess impact, identify corrective / preventive actions, present to management and close investigations in the Quality Management System (QMS).
The Reviewers in this role will be responsible for executing root cause investigations, owning/authoring deviations, driving continuous improvement efforts.
They will also manage both minor and major investigations as relates to Batch Record reviews.
Work on a team under a Senior Manager.
Cell/Gene Therapy experience preferred.
The Lead Reviewer will also be responsible for reporting to the client management on a weekly basis on review details, project progress and project metrics, as well as providing coaching and training for the staff reviewers.